NEW PROVIDENCE, N.J.,
Feb. 24, 2021 /PRNewswire/
-- Vertice Pharma ("Vertice"), a specialty pharmaceuticals
company focused on improving patients' health, today announced
the launch of THYQUIDITY. THYQUIDITY is indicated as a replacement
therapy in primary (thyroidal), secondary (pituitary), and tertiary
(hypothalamic) congenital or acquired hypothyroidism and as an
adjunct to surgery and radioiodine therapy in the management of
thyrotropin-dependent well-differentiated thyroid
cancer.*
THYQUIDITY is a liquid dosage form of levothyroxine administered
by a calibrated oral syringe, and is designed to deliver
individualized dosing for patients. THYQUIDITY is a liquid oral
solution of levothyroxine sodium containing 100 mcg per 5 mL (20
mcg per mL), and it is supplied in a package of two 100 mL
bottles. THYQUIDITY offers broad dosing flexibility for
patients, as well as consistent daily dosing.
"The launch of THYQUIDITY marks our first branded pharmaceutical
prescription product and reflects our ongoing mission to deliver
high-quality and affordable pharmaceutical products for patients.
Vertice is committed to providing branded and specialty generics
products and we look forward to building off the momentum of
today's launch," said Scott Meyers,
Chief Executive Officer of Vertice Pharma.
Vertice's co-promotion partner is MannKind Corporation (Nasdaq:
MNKD). MannKind's sales force will promote THYQUIDITY to adult
and pediatric endocrinologists and other U.S. healthcare providers
who treat hypothyroidism.
"THYQUIDITY fits nicely into our product portfolio of branded
and specialty generics and is an exciting launch for the team at
Vertice. As we continue to evaluate select opportunities to bring
products to market, we are proud to have partnered with MannKind in
the launch of this important product," said John Walsh, Head of Specialty Sales and
Marketing at Vertice Pharma.
Hypothyroidism, also called underactive thyroid disease, is a
common disorder in which the thyroid gland does not produce enough
thyroid hormone to meet the needs of the body. The prevalence of
hypothyroidism is 4.6% in the US population.1
Symptoms include fatigue, lethargy, cold intolerance, weight
gain, constipation, change in voice, and dry skin.2 Most
patients require lifelong therapy to treat their
hypothyroidism.3
Vertice Pharma was founded in 2015 with a unique focus on
acquiring specialty pharmaceutical companies and products,
including both branded and generic products, to create a durable
specialty pharmaceutical business of scale.
Patient Use and Important Safety Information
USE
THYQUIDITYTM (levothyroxine sodium) oral solution is
a prescription, man-made thyroid hormone that is used to treat a
condition called hypothyroidism. It is meant to replace a hormone
that is usually made by your thyroid gland. Generally, thyroid
replacement treatment is to be taken for life. THYQUIDITY should
not be used to treat noncancerous growths or enlargement of the
thyroid in patients with normal iodine levels, or in cases of
temporary hypothyroidism caused by inflammation of the thyroid
gland (thyroiditis).
IMPORTANT SAFETY INFORMATION
- Thyroid hormones, including THYQUIDITY, either alone or in
combination with other drugs, should not be used for the treatment
of obesity or weight loss. In patients with normal thyroid levels,
doses of THYQUIDITY used daily for hormone replacement are not
helpful for weight loss. Larger doses may result in serious or even
life-threatening events, especially when used in combination with
certain other drugs used to reduce appetite.
- Do not use THYQUIDITY if you have uncorrected adrenal
problems.
- Tell your doctor about any other medical conditions you may
have, especially heart disease, diabetes, blood clotting problems,
and adrenal or pituitary gland problems. The dose of other drugs
you may be taking to control these conditions may have to be
changed while you are taking THYQUIDITY. If you have diabetes,
check your blood sugar levels and/or the glucose in your urine, as
ordered by your doctor, and immediately tell your doctor if there
are any changes. If you are taking blood thinners, your blood
clotting status should be checked often.
- Taking too much levothyroxine has been associated with
increased bone loss, especially in women after menopause.
- Once your doctor has found your specific THYQUIDITY dose, it is
important to have lab tests done, as ordered by your doctor, at
least once a year.
- Foods like soybean flour, cottonseed meal, walnuts, and dietary
fiber may cause your body to absorb less THYQUIDITY from the
gastrointestinal tract. Grapefruit juice may cause your body to
absorb less levothyroxine and may reduce its effect. Let your
doctor know if you eat these foods, as your dose of THYQUIDITY may
need to be adjusted.
- Use THYQUIDITY only as ordered by your doctor. Take THYQUIDITY
as a single dose, preferably on an empty stomach, one-half to one
hour before breakfast.
- Products such as iron and calcium supplements and antacids can
lower your body's ability to absorb levothyroxine, so THYQUIDITY
should be taken 4 hours before or after taking these products.
- Tell your doctor if you are pregnant or breastfeeding or are
thinking of becoming pregnant while taking THYQUIDITY. Your dose of
THYQUIDITY may need to be increased during your pregnancy.
- Monitor your baby from birth to 3 months of age for vomiting
and/or diarrhea as THYQUIDITY can cause gastrointestinal irritation
due to the glycerol component.
- It may take several weeks before you notice an improvement in
your symptoms.
- Tell your doctor if you are taking any other drugs, including
prescription and over-the-counter products.
- Tell your doctor or dentist that you are taking THYQUIDITY
before any surgery.
- Tell your doctor if you develop any of the following symptoms:
rapid or abnormal heartbeat, chest pain, difficulty catching your
breath, leg cramps, headache, nervousness, irritability,
sleeplessness, shaking, change in appetite, weight gain or loss,
vomiting, diarrhea, increased sweating, difficulty tolerating heat,
fever, changes in menstrual periods, swollen red bumps on the skin
(hives) or skin rash, or any other unusual medical event.
- Partial hair loss may occur during the first few months you are
taking THYQUIDITY.
This is the most important safety information you should know
about THYQUIDITY. For more information, talk with your
doctor.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.
Please
see:
http://www.thyquidity.com/pdf/Prescribing-Information.pdf for
full US Prescribing Information including Boxed Warning.
About Vertice Pharma
Vertice Pharma is a specialty pharmaceutical company focused on
improving patients' health. Vertice Pharma develops, manufactures,
markets, and distributes high-quality and affordable pharmaceutical
products through its operating companies. Vertice Pharma has global
headquarters in the United Kingdom and United
States headquarters in New Jersey. For more information
visit www.verticepharma.com.
References
- Hollowell JG, Staehling NW, Flanders WD, Hannon WH, Gunter EW,
Spencer CA, Braverman LE. Serum TSH, T(4), and thyroid antibodies
in the United States population
(1988 to 1994): National Health and Nutrition Examination Survey
(NHANES III). J Clin Endocrinol Metab. 2002 Feb;87(2):489-99. doi:
10.1210/jcem.87.2.8182. PMID: 11836274.
- Chaker L, Bianco AC, Jonklaas J, Peeters RP. Hypothyroidism.
Lancet. 2017;390(10101):1550-1562.
https://pubmed.ncbi.nlm.nih.gov/28336049/
- Jonklaas J, Bianco AC, Bauer AJ, et al. Guidelines for the
Treatment of Hypothyroidism: Prepared by the American Thyroid
Association Task Force on Thyroid Hormone Replacement. Thyroid.
2014;24(12):1670-1751.
https://www.ncbi.nlm.nih.gov/pubmed/25266247.
* Please see
http://www.thyquidity.com/pdf/Prescribing-Information.pdf for
full US Prescribing Information including Boxed Warning.
Company Media Contact:
Vertice Pharma
Kimberly Branch
kbranch@vistapharm.com
727-530-1633 x276
THYQUIDITY is a trademark of VistaPharm, Inc. ©
2021 VistaPharm, Inc. All rights reserved.
THQ_0027 0221
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SOURCE Vertice Pharma